This prospective randomized pilot study evaluates the feasibility, acceptability, and preliminary efficacy of the Patient-Controlled Dispenser and Deactivator (PCDD) Generation 1 system for patient-controlled oral liquid acetaminophen administration in postoperative total shoulder replacement inpatients compared with standard nurse-administered oral acetaminophen delivery.
The primary objective of this prospective pilot study is to determine the feasibility of patient-controlled administration of liquid oral acetaminophen using the Patient-Controlled Dispenser and Deactivator (PCDD) system, using recruitment rate and cross-over rates as surrogate markers. The secondary objective of this study is to determine the preliminary efficacy of patient-controlled delivery of oral acetaminophen administration using the PCDD system.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Dispenses prescribed oral liquid medication through a secure, patient-activated mechanism . The system provides access to as needed oral liquid doses only within the prescribed dosing eligibility window.
Yale New Haven Hospital SRC
New Haven, Connecticut, United States
Participant enrollment rate
Percent participants enrolled out of all screened
Time frame: 1-7 days prior to surgery
Retention in assigned treatment group
Percentage of participants who remain in their assigned treatment group for the duration of study participation.
Time frame: From enrollment to discharge, up to 3 days
Mean score Patient Questionnaire
Patient satisfaction with PCDD system. Total score range 0-10 with higher scores indicating more satisfaction.
Time frame: Baseline up to Day 3
Mean score Nurse Questionnaire
Nurse satisfaction with PCDD system. Total score range 0-10 with higher scores indicating more satisfaction.
Time frame: Baseline up to Day 3
Mean Acetaminophen consumption
Postoperative acetaminophen consumption in milligrams will be monitored between anesthesia end time and discharge time.
Time frame: From anesthesia end time to discharge time, up to 48 hours
Mean Opioid consumption
Postoperative opioid consumption in oral milligram morphine equivalent (OME) will be monitored between anesthesia end time and discharge time.
Time frame: From anesthesia end time to discharge time, up to 48 hours
Mean Pain scores
Participants will be asked via Pain Diary to rate their pain using numeric pain scores from 0 to 10, 0 as no pain, 10 is the worst possible.
Time frame: From anesthesia end time to discharge time, up to 48 hours
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Mean Time to first opioid request
Mean time in minutes from the time when opioid medication requested by the participant to the time opioid medication is delivered
Time frame: From anesthesia end time to discharge time, up to 48 hours
Mean time to medication delivery
Mean time in minutes from the time when pain medication requested by the participant to the time pain medication is delivered
Time frame: From anesthesia end time to discharge time, up to 48 hours
Mean awake time to assess sleep disruption related to pain control
Awake time (hours) at night/Sleep loss due to poor pain control
Time frame: From anesthesia end time to discharge time, up to 48 hours
Mean number of pain-related nursing calls
Mean number of postoperative pain-related nursing calls
Time frame: From anesthesia end time to discharge time, up to 48 hours